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Packaging and Labeling Submissions

to the NVSL

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The packaging and labeling of biological substances for shipment requires familiarity

with current rules and regulations, which frequently change. Shippers are

responsible for proper packaging, marking and labeling, documentation,

classification, and identification of each shipment. Failure to follow regulations

can result in substantial financial penalties.

Applicable Regulations

Anyone sending material to the NVSL should be in compliance with all applicable

regulations. Regulations governing packaging and labeling of interstate shipments of

etiologic agents are found in:

Title 9 Code of Federal Regulations (CFR), Parts 121 and 122: These USDA

regulations cover (1) the transfer of select agents/toxins and (2) the permits

needed to ship organisms and vectors.

Title 49 CFR Part 173: These U.S. Department of Transportation regulations

contain general requirements for shipments and packaging. 

49 CFR 173.134 defines infectious substances and related terms. 
49 CFR 173.217 has additional requirements for shipments containing

solid carbon dioxide (dry ice).

Airline shipments also should be in compliance with current International Air

Transport Association (IATA) regulations for dangerous goods.

Definitions

All specimens or reagents sent to the NVSL (Ames or Plum Island) are biological

substances. These include, but are not restricted to, excreta, secreta, blood, serum,

tissues, organs, animals or animal parts, tissue cultures, and viruses or other

microorganisms (either infectious or inactivated).

Biological materials that are known to contain, or could contain, etiologic agents are

divided into two groups:

1. Biological Substance, Category A: Materials known to contain certain

etiologic agents (i.e., an infectious substance transported in a form which,

when exposure occurs, is capable of causing permanent disability or a lifethreatening or fatal disease to humans or animals)

2. Biological Substance, Category B: Excreta, secreta, blood and its

components, tissue, tissue fluids, etc., which the shipper reasonably believes

may contain an etiologic agent and that is being shipped for purposes of

diagnosis (i.e., a diagnostic specimen) or investigation.

General Recommendations

For routine serological testing, submit one tube containing 2 milliliters (ml) of

clear serum per animal for each test requested. (Disease investigation cases

may require additional volume.) Label each tube with the Sample ID, exactly as

indicated in Block 21 in Form VS 10-4.

If virus detection is required from serologic specimens, contact the

appropriate laboratory for volume requirements.

Pack fresh and formalin-fixed specimens separately. Ship in separate containers

when possible.

Double bag all fresh tissues.

Formalin-fixed specimens: Specimens may be shipped in a plastic specimen jar

containing a 10:1 (liquid to tissue) volume of formalin. Do not use bags

(Whirlpacks, zipper-closure, or heat-sealed) in lieu of a jar. Alternatively,
adequately fixed specimens may be removed from formalin, wrapped with

formalin saturated gauze or paper towels, and then placed in a leak-proof

plastic bag. Submission forms should be protected by placing in separate

sealed bag.

Cool with ice packs if the sample will reach the NVSL within 24 hours. Use

"foam" ice, picnic packs, or sealed frozen containers of ice. Never use cubed or

crushed ice, even if it is enclosed in a plastic bag.

If tissues or swabs are to be in transit more than 48 hours, package with dry

ice, unless the samples should not be frozen. When using dry ice, tightly seal all

containers; CO2 gas can inactivate some viruses and prohibit diagnostic

isolation. Do not freeze dry ice or use dry ice in boxes that contain formalinfixed tissues. Dry ice is considered a dangerous good; packages with dry ice

must meet Category A Biological Substance shipping requirements, and not all

carriers will accept packages containing dry ice.

Packaging and Labeling Submissions

Packaging kits are available upon request from the NVSL. These kits contain

instructions, labels, an acceptable secondary vessel, and a shipping box meeting

drop-test requirements. Contact the NVSL Shipping Department at 515-337-6614 for

more information.

The following information is intended as a general guideline only. Shippers should

read official rules and regulations for detailed information.

Category B Biological Substances (most diagnostic specimens)

Packaged according to regulations in 49 CFR 173.199

Place samples in a sealed primary container. Maximum volume per primary

container is 1 liter (L).

Wrap the primary container in sufficient dry absorbent material (for example,

cotton) to absorb liquid contents in case of breakage. Do not use sawdust or

vermiculite. Absorbent material is not required for solid shipments unless there

is a risk of residual liquid.

Place the primary container in a secondary container. The primary or secondary

container must be able to withstand a 95 kPa pressure test.
Place the secondary container in a certified outer box that will pass a 1.2-meter

drop test. The maximum liquid volume allowed per box is 4 L. Solids must not

exceed 4 kilograms (or 8 pounds) per box.

Include an itemized list of contents between the secondary container and the

outer box.

Label the box properly. Mark the proper shipping name (Biological Substance,

Category B) in letters at least 5 millimeters high adjacent to a "UN3373" mark

or label. Add the name, address, and telephone number of the shipper and the

consignee.

Add the NVSL Priority Designation to the shipping box and the submission form.

Samples preserved in formaldehyde are exempt from Category B regulations

provided that the concentration of formaldehyde does not exceed 10 percent.

Category A Biological Substances (known etiological agents)

Packaged in accordance with regulations in 49 CFR 173.196 .

Category A samples must be packaged to withstand leakage of contents,

shocks, pressure changes, and other conditions in ordinary transportation

handling.

Individuals shipping Category A items must be certified shippers, formally

trained in handling Dangerous Goods. Certification is needed to sign the

"Declaration of Dangerous Goods" form.

Follow the procedures for Category B, with the following additional procedures:

The primary container must be watertight and sealed with waterproof

tape. The primary container must contain a label identifying the contents.

Each primary container must be separately wrapped with packing

material.

The name, address, and telephone number of the shipper must be on the

secondary container.

The outer box requires an Infectious Substance label. The UN number is

UN2814 or UN2900, depending on known medical history, symptoms of

the source (human or animal), endemic local conditions, and professional

judgment.

Interstate movement of Category A substances requires a US Veterinary

Permit for the Importation and Transportation of Controlled Material and

Organisms and Vectors. The permit is provided by the recipient of the

shipment.
To submit Category A substances to the NVSL, a copy of the

necessary permit must be enclosed in the shipment.

Individuals wishing to receive Category A substances from the NVSL

must apply for a permit from the National Center for Import and

Export.

Place one copy of the permit in the shipping box, outside the

secondary container. Affix five additional copies to the outside of the

shipping box.

Affix a signed Declaration of Dangerous Goods form to the outer box. 

Packages containing dry ice are handled as Category A shipments. Place dry ice

between the secondary container and outer shipping container. Add a Dry Ice

(medical use only) label to the outer box.

Shipments over 50 ml or 50 grams must be sent by cargo aircraft only.

Related Resources

Brochure: Transporting Infectious Substances Safely (U.S. Department of

Transportation)

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